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Neuren gains FDA orphan status for NNZ-2591 in neonatal brain injury

10:37am on Monday 2nd of November, 2026 AEDT • Biotechnology and Pharmaceuticals
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Neuren gains FDA orphan status for NNZ-2591 in neonatal brain injury

10:37am on Monday 2nd of November, 2026 AEDT
Key Points
  • FDA orphan designation for NNZ-2591 in neonatal HIE
  • Potential seven-year US marketing exclusivity
  • Juvenile animal safety study underway
  • IND application planned for H1 2027
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